PMA · Approved
ApprovedAlinity m CMV
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Molecular, Inc. · PAB Cytomegalovirus (Cmv) Dna Quantitative Assay
Approved on May 5, 2022 through premarket approval, which rests on the device’s own clinical evidence after a 338-day review. 1 later device descends from it.
- Decided
- May 5, 2022
- Review
- 338 days
- Class
- Class II
- Product code
- PAB
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceP210022 Alinity m CMVAbbott Molecular, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK243485 Alinity m CMVAbbott Molecular, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K243485Alinity m CMVAbbott Molecular, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P210022 | Alinity m CMV | Abbott Molecular, Inc. | 2022 | — |
| +1 | K243485 | Alinity m CMV | Abbott Molecular, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PAB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PAB device
- #1 K252481 cobas CMVscore 10.3 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243485 | Alinity m CMV | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K243485 (Abbott Molecular, Inc., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All PAB devicesPAB Cytomegalovirus (Cmv) Dna Quantitative Assay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · PAB
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PAB
88in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PAB
No recall names PAB since 2007.
Adverse event reports per year · PAB
4in 2025
MAUDE reports naming product code PAB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 3 | — | 0 | 0 |
| 2013 | 10 | — | 0 | 0 |
| 2014 | 4 | — | 0 | 1 |
| 2015 | 8 | — | 0 | 2 |
| 2016 | 7 | — | 0 | 1 |
| 2017 | 13 | — | 0 | 1 |
| 2018 | 24 | — | 0 | 2 |
| 2019 | 21 | — | 0 | 1 |
| 2020 | 8 | — | 0 | 0 |
| 2021 | 4 | — | 0 | 0 |
| 2022 | 9 | — | 0 | 1 |
| 2023 | 14 | — | 0 | 3 |
| 2024 | 16 | — | 0 | 2 |
| 2025 | 3 | 88 | 0 | 4 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/P210022 · printed Nov 5, 2026
Cite this page
510(k) Report. “P210022: Alinity m CMV.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/P210022
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026